Theriva Biologics reports no significant changes to explain unusual trading activity.
Unusual Trading Activity: Theriva Biologics reported unusual trading activity in its common stock on the NYSE American on October 24, prompting inquiries by the company.
No Corrective Actions Needed: The company concluded that no corrective actions were necessary and stated there were no undisclosed material developments affecting the unusual market activity.
VIRAGE Trial Presentation: On October 13, 2025, Theriva announced the presentation of expanded data from its VIRAGE trial investigating VCN-01 at a session during the European Society for Medical Oncology Annual Congress.
Market Response: Despite the unusual trading, Theriva emphasized that it was unaware of any reasons for the market fluctuations beyond the previously disclosed information.
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Theriva Biologics Receives EMA Support for Phase 3 Trial of VCN-01
- Strong Stock Performance: Theriva Biologics' stock rose 4.03% on Monday with a trading volume of 114.18 million shares, significantly exceeding the average volume of 15.61 million shares, indicating positive market sentiment regarding its clinical advancements.
- Clinical Trial Design Approved: The company received Scientific Advice from the EMA's Committee for Medicinal Products for Human Use, supporting its Phase 3 trial design for VCN-01, aimed at evaluating its efficacy in combination with standard chemotherapy, potentially offering new treatment options for pancreatic cancer patients.
- Survival Rate Improvement: In the previous VIRAGE Phase 2 trial, patients treated with VCN-01 in combination with standard chemotherapy demonstrated higher overall survival and progression-free survival rates, particularly those receiving two doses of VCN-01, further validating the drug's potential efficacy.
- Healthy Cash Position: As of November 10, 2025, Theriva had $15.5 million in cash and equivalents, providing a runway into the first quarter of 2027, facilitating interactions with regulatory agencies and scaling up VCN-01 manufacturing.

Theriva Receives EMA Approval for Phase 3 Trial of VCN-01 in Metastatic PDAC
- Trial Design Approval: Theriva has received EMA approval for the Phase 3 trial design of VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, which is expected to significantly enhance patient survival and treatment outcomes.
- Funding Runway Until 2027: Theriva's cash reserves are projected to last until Q1 2027, ensuring the company can complete regulatory activities and trial designs, thereby strengthening its competitive position in cancer treatment.
- FDA Meeting Scheduled: Theriva plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, further advancing VCN-01's path to market.
- Potential of Multi-Dose Regimen: EMA acknowledged the significant survival improvement in patients receiving two doses of VCN-01 in the VIRAGE study, and Theriva plans to explore the application of three or more doses in the Phase 3 trial to achieve even better therapeutic outcomes.








